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Oklahoma Administrative Code (Last Updated: March 11, 2021) |
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TITLE 535. Oklahoma State Board of Pharmacy |
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Chapter 20. Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third- Party Logistics Providers, and Medical Gas Suppliers and Distributors |
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Subchapter 3. Manufacturers |
SECTION 535:20-3-5.1. Personnel
Latest version.
- (a) Manufacturers shall establish and maintain for Board inspection a list of each partner, limited liability company member or corporate officer and corporate director, as well as designated representatives and facility managers, including a description of their duties and a summary of their qualifications.(b) Each manufacturer shall designate, in writing on a Board-approved form, a person to serve as the designated facility manager of the manufacturer for each location licensed. The facility manager is responsible for all aspects of the operation of the manufacturer.(c) No manufacturer shall have as an owner, designated representative or facility manager anyone convicted of any felony for conduct relating to manufacturing prescription drugs, any felony for violation of 21 U.S.C. § 331(i) or (k) or any felony for violation of 18 U.S.C. § 1365 relating to product tampering. No manufacturer shall have as an owner, designated representative or facility manager anyone who has violated federal or state requirements for licensure that presents a threat of serious adverse health consequences or death to humans.